Device for reducing the retraction of a fascia or a soft tissue mantle in an open soft tissue defect

ABSTRACT

The invention relates to a device for reducing the retraction of the edges (4.1) of an opened fascia (4) of a patient (1) having an open soft tissue defect, in particular having an open abdominal wall (2) or an open soft tissue defect on the back, via which a tensile force (A, B) can be applied to the edges (4.1) of the fascia (4) by a force component (A1, B1) directed away from the body of the patient (1), such that the device (11) holds the edges (4.1) of the fascia (4) under tension and spaced apart from each other and that furthermore there is an open soft tissue defect, in particular an opened abdominal wall (2), or an open soft tissue defect on the back. The invention further relates to a kit for treating an open soft tissue defect, in particular of an opened abdominal wall (2) or of an open soft tissue defect on the back, having at least one sponge (9, 15, 28) for filling out an opening (7) of a soft tissue defect, in particular in the abdominal wall or of en open soft tissue defect on the back, and having such a device (11) for reducing the retraction of the edges (4.1) of an opened fascia (4).

FIELD OF THE INVENTION

The invention relates to an apparatus and a method for reducing theretraction of the edges of an open fascia of a patient with an open softtissue defect, in particular with an open abdominal wall or an open softtissue defect on the back. The invention also relates to a kit fortreating an open soft tissue defect, in particular an opened abdominalwall or an open soft tissue defect on the back, having at least onesponge for filling a soft tissue defect, in particular an opening in theabdominal wall or an open soft tissue defect on the back.

A sponge for negative-pressure wound therapy is also described.

The invention may be used in the case of open soft tissue defects. Suchsoft tissue defects may exist for example in the form of an abdominalwall defect, a back wall defect, a soft tissue defect in the region ofthe hip, or a soft tissue defect on the limbs.

PRIOR ART

For the treatment of certain abdominal illnesses associated with anintra-abdominal pressure increase, an abdominal compartment syndrome, itmay be necessary for the abdominal wall to be opened up in order toexpose the abdominal cavity and counteract an increase of theintra-abdominal pressure. This state is also referred to as “openabdomen”. Here, the abdominal wall remains widely opened normally for aperiod of several days up to a number of months. An open abdomen mayalso be necessary, or involved, in the case of other diagnoses withoutan intra-abdominal pressure increase.

In general, the abdominal wall is temporarily sealed off by way of atemporary abdominal closure in the form a vacuum bandage, such thatnegative-pressure wound therapy can be performed. Here, a sponge-likematerial is inserted into the gap in the abdominal wall, and the openabdomen is sealed off by way of films. By way of the sponge, a negativepressure is applied, and excess liquid is drawn out of the abdominalcavity. Alternatively, the wound may also be tended to withoutnegative-pressure wound therapy.

Therapy by way of an open abdomen has proven to be particularlyadvantageous for the healing of illnesses of the abdominal cavity.Opening the abdominal wall however has the disadvantage that the edgesof the opened fascia situated in the abdominal wall can retract in thedirection of the sides while the abdomen is open for days or weeks. As aresult, closing the abdominal wall and thus the fascia afternormalization of the intra-abdominal pressure is made difficult orimpossible. Primary wound healing, in the case of which the wound edgeslie against one another, is often not possible. Even secondary woundclosure by layers can often not be achieved. It may be the case thatsecondary wound healing occurs over a long period of time, which isassociated with the formation of scar tissue. The wound often heals withan incisional hernia.

To bridge the time until permanent closure of the abdominal wall occurs,and to bring the edges of the fascia closer to one another, it is oftenthe case after therapy by way of an open abdomen that the abdominal wallis closed only temporarily. For example, DE 36 31 762 A1 has disclosed atemporary closure for an abdominal wall opening, by way of which theabdominal wall can be temporarily closed and, in the process, a tensionis exerted on the edges of the fascia. DE 4034 705 A1 discloses afurther temporary closure in the case of which a tension is imparted tothe edges of the open fascia. Furthermore, DE 34 44 782 C2 describes asliding closure which can be sewn to the edges of the open fascia inorder to close the latter.

In the case of the abovementioned temporary abdominal wall closures, theedges of the open fascia are placed under tension, such that subsequentpermanent closure of the fascia by way of primary wound healing is madepossible. In the case of these closures, the fascia edges are pulledtoward one another so as to bear against one another. Since, in the caseof these temporary closures, the abdominal cavity is not open, theabdominal organs of the patient cannot expand, which is however vitalfor patients with an increase in intra-abdominal pressure. It is oftennecessary, owing to the retracted fasciae after the in any caserelatively long period of the abdomen being open, for the abdominal wallto remain only temporarily close for a relatively long period of timebefore the permanent closure of the abdominal wall can be performed.This is often realized only with the aid of alloplastic materials.

The publication “Sekundärverschluß von Hautdefekten unter Anwendung vonGummizügen (dynamische Sekundërnaht)” [“Secondary closure of skindefects using rubber cords (dynamic secondary seam)”], Fankhauser etal., Chirurg (1995) 66, 1154-1157, ISSN 0009-4722, discloses a secondarywound closure for a skin defect in the region of the limbs, in the caseof which the skin edges are pulled toward one another by way oftranscutaneously or intracutaneously fixed rubber cords. With thismethod, although it is possible to stretch the skin in order to permit asecondary closure of the skin, it is a disadvantage that reduction ofthe retraction of the fasciae lying under the skin, in particular whilethe fascia opening exists, cannot be achieved. A further disadvantage ofsaid apparatus consists in that the apparatus is supported on the skinedges on which a pulling action is exerted, whereby the space situatedunder the skin defect is reduced in size.

The abovementioned disadvantages also arise in the case of other opensoft tissue defects, such as for example an open back wall or an opensoft tissue defect in the region of the hip or on the limbs. In theregion of the back, it may for example be necessary after an operationfor the back wall to be left open for treatment of infections, wherein aretraction of the fasciae may likewise occur.

DISCLOSURE OF THE INVENTION

Against this background, it is the object of the invention to permit thepermanent closure of the soft tissue defect, in particular of theabdominal wall or of the back wall, immediately after therapy with anopen soft tissue defect, in particular with an open abdomen or an openback wall.

The object is achieved by way of an apparatus for reducing theretraction of the edges of an open fascia of a patient with an open softtissue defect, in particular with an open abdominal wall or an open softtissue defect on the back, by way of which apparatus a tensile forcewith a force component directed away from the body of the patient can beexerted on the edges of the fascia such that the apparatus holds theedges of the fascia under tension and spaced apart from one another andsuch that an open soft tissue defect, in particular an opened abdominalwall or an open soft tissue defect on the back, remains present.

By way of the tensile force acting on the fascia, the edges of theopened fascia are held spaced apart, such that access to the body cavitysituated under the soft tissue defect, in particular to the abdominalcavity, is possible, negative-pressure wound therapy, for example, canbe performed, or the abdominal organs can expand through the softtissue, defect, in particular the abdominal wall opening or a softtissue defect on the back. Furthermore, by way of the tensile force, thetension of the fascia is maintained, and thus the retraction of theedges of the fascia is at least reduced. After the completion of thetherapy by way of an open soft tissue defect, in particular by way of anopen abdomen or open soft tissue defect on the back, the edges of thefascia can be laid against one another and directly closed, wherebyimproved wound healing with permanent closure of the soft tissue, inparticular of the abdominal wall or of the back wall, is made possible.

By way of the apparatus according to the invention, the fascia can beheld open to such an extent that the body cavity situated under the softtissue defect, in particular the abdominal cavity, is freely accessible,and/or the internal organs can emerge at least substantially unhinderedthrough the skin defect, in particular the abdominal wall opening or theback wall opening. This yields the advantage that an unhindered releaseof an excess pressure in the body, in particular in the abdominal cavityor in the cavity below the back wall, or the unhindered escape of excessfluid from the body, in particular from the abdominal cavity of thecavity below the back wall, is possible. According to the invention, theedges of the opened fascia are held by way of the tensile force so asnot to lie against one another. The apparatus is preferably designedsuch that no connecting means arranged in the plane of the body surface,in particular of the abdominal wall or back wall, is arranged betweenthe fascia edges.

The apparatus according to the invention permits an increase in volumeof the body cavity originally situated under the soft tissue defect byway of an expansion into the space originally occupied by the softtissue.

It is particularly preferably the case that the tensile force impartedby way of the apparatus is oriented such that the edges of the openedfascia are not pulled toward one another. In this respect, the tensileforce is preferably exerted on the edges of the fascia such that theopen soft tissue defect is not reduced in size. The tensile force isadvantageously oriented such that the space bordered by the edges of thefascia is increased in size.

The apparatus may be designed such that the tensile force engages on thefascia of the abdomen substantially in a ventral direction or in aventrolateral direction or in a lateral direction. Alternatively, theapparatus may be designed such that the tensile force engages on thefascia of the back in a dorsal direction or dorsolateral direction. Itis preferably the case that at least one component of the tensile forceis oriented transversely, in particular perpendicular, to a virtualconnecting line between the edges of the body opening, in particularopened abdominal wall or opened back wall, or of the opened fascia. Thetensile force acting on the edges of the fascia thus has a componentrunning away from the patient transversely, in particularperpendicularly, to the body opening, in particular abdominal wallopening or back wall opening. The edge of the fascia may however also befolded over and then held under tension. In this case, the tensile forceis directed substantially parallel to the body surface, in particular tothe abdominal wall or back wall, of the patient but away from the bodyopening, in particular the abdominal wall opening or back wall opening.

In one advantageous refinement, the apparatus is designed such that thetensile force engages on the fascia in a direction which encloses anangle in the range of 5° to 90°, or in the range of 10° to 80° or in therange of 15° to 70°, with a virtual connecting line between the edges ofthe opened fascia. The angle preferably lies in the range from 30° to60°, particularly preferably in the range from 35° to 55°. The angle mayfor example amount to substantially 45°.

It is advantageous if the apparatus has at least one tensile elementthat can be connected to the fascia. The tensile force can be introducedinto the fascia by way of the tensile element. It is preferable formultiple tensile elements to be provided by way of which tensile forcescan be exerted on the edges of the opened fascia at several differentpoints. The various tensile elements may in each case introduce tensileforces of different magnitude and different orientation into the fascia.Alternatively, the tensile element may be connected to the body surface,in particular to the abdominal wall or back wall, including the fascia,such that not only the fascia but also the skin lying over the fascia isheld under tension.

The tensile element is preferably in the form of a thread and/or in theform of a wire and/or in the form of a mesh. Use may be made ofconventional threads, wires or meshes that are used in surgery. It isparticularly advantageous if the tensile element has a spring meanswhich can be preloaded in the direction of the tensile force, such thatthe tensile element can be held under stress. Alternatively or inaddition, the tensile element may be of elastic form and preloaded inthe direction of the tensile force. The tensile element may be attachedto the fascia directly or indirectly by way of a connecting means. Thetensile element is preferably in the form of a combination of a threadand/or of a wire and/or of a mesh.

It is also preferable if the tensile element can be connected to thefascia by way of a connecting means of an areal form. By way of theaerial connecting means, an improved attachment of the tensile elementto the fascia, can be realized. The risk of the fascia being torn outcan be reduced, and the fascia can be protected in the case of repeatedexchange of the tensile element. A refinement is particularly preferablein which the areal connecting means can be sewn to the fascia.Alternatively, the connecting means may for example have hooks, inparticular barbs, which can be introduced into the fascia. Theconnecting means may for example be in the form of a mesh or in the formof a plate. The tensile element may be connectable by way of theconnecting means of areal form to the fascia and additionally to otherconstituent parts of the soft tissue mantle, preferably to the entiresoft tissue mantle. For example, aside from the fascia, the skin mayalso be connected to the areal connecting means.

It is advantageous if the connecting means of areal form can beconnected reversibly to the tensile element, such that the tensileelement and/or the mounting bracket can be easily removed and attachedagain for the purposes of treating the open soft tissue defect, inparticular the open abdomen or the open back.

The apparatus advantageously has a mounting bracket which can bearranged outside the body of the patient and to which the tensileelement can be attached. The mounting, bracket may be positioned infront of the soft tissue defect, in particular the abdominal wallopening or back wall opening, of the patient. It is possible for one endof the tensile element to be attached to the mounting bracket, and forthe other end of the tensile element to be attached to the fascia. It isalternatively possible for both ends of the tensile element to beattached to the fascia and for the tensile element to be guided over adiverting device arranged on the mounting bracket. The two ends of thetensile element may be attached to the same edge section of the openedfascia or to different edge sections of the opened fascia.

In one advantageous refinement, the tensile elements are attached to themounting bracket such that a tensile force is exerted on the edges ofthe fascia by way of the tensile elements, which tensile force acts in adirection which encloses an angle which lies in the range from 5° to 90°or in the range from 10° to 8°, or in the range from 15° to 70°, with avirtual connecting line between the edges of the opened fascia. Theangle preferably lies in the range from 30° to 60°, particularlypreferably in the range from 35° to 55°. The angle may for exampleamount to substantially 45°.

It has also proven to be advantageous if the tensile force can beadjusted by way of a tensioning apparatus arranged in particular on themounting bracket. The tensioning apparatus may be manually actuable,such that the tension of individual tensile elements or the tension of agroup of tensile elements can be adjusted while the soft tissue defect,in particular the opened abdomen or the opened back wall, exists. It isthus possible to react to changes of the fascia, and to adjust thetension if necessary. Alternatively, the tensioning apparatus may bedesigned so as to automatically re-tension the tensile element as soonas a relaxation of the tensile element occurs. The tensioning apparatusmay have a force booster, for example a lever-type force booster, suchthat the tensile force can be adjusted by way of an adjustment forcewhich is lower than the tensile force.

The tensioning apparatus is preferably designed such that the tensileforce acting on the fascia can be adjusted without the tensile elementbeing released from the fascia and/or from the mounting bracket. It isadvantageous if each tensile element is assigned a dedicated tensioningapparatus such that the tension of the tensile elements can beindividually set. Alternatively or in addition, a tensioning apparatusmay be assigned to a group of tensile elements, such that the stress ofthe tensile elements of the group can be adjusted jointly.

It is also advantageous if the apparatus has a protective apparatuswhich, in the event of a predefined tensile force being exceeded, placesa tensile element or multiple tensile elements into a protective statein which the tensile force exerted on the fascia by way of the tensileelement is reduced. This yields the advantage that the fascia can beprotected against the exertion of excessively high tensile forces. Inthe protective state, the tensile element may be released from thefascia and/or from the mounting bracket. It is furthermore possible forthe tensile element to be relaxed in the protective state.

A preferred refinement provides that the mounting bracket can bearranged so as to run vertically, that is to say parallel to animaginary line between the head and feet of the patient, along theabdomen or along the back. The mounting bracket may be arranged from theregion of the sternum into the region of the anterior pelvic ring, suchthat a mounting bracket running craniocaudally is formed. The mountingbracket may have one or more, in particular vertically running, rods. Itis alternatively possible for the mounting bracket to be formed in themanner of a frame which can be arranged around the soft tissue defect,in particular around the opening of the abdominal wall. In the case of amounting bracket with rods, the rods preferably run in straight orcurved fashion. The rods advantageously have a polygonal or circularcross section.

The mounting bracket can preferably be attached to the body of thepatient, such that, when the patient changes position, the mountingbracket can move together with the patient. The attachment may berealized by way of a fastening device, in particular a strap-typefastener or a fastening chain, which can be fixed to the body of thepatient. It is possible for multiple fastening devices to be provided.An embodiment is preferable which has two fastening devices which can bearranged in the upper (cranial) and lower (caudal) region of the abdomenor of the back.

The fastening device is preferably designed such that it can be appliedto the skin of the patient or can be fastened to a bone of the patient.The fastening may be realized for example to the sternum and/or to theanterior pelvic ring. For the fastening of the fastening device to abone, the fastening device may preferably be fixed in the bone, forexample by virtue of the fastening device, and/or a connecting meansconnected to the fastening device, being screwed or pushed or driveninto the bone.

An advantageous refinement provides that the fastening device isdesigned as a corset which can be fixed to the body of the patient.

The fastening device of the apparatus is preferably provided such thatsaid fastening device can be applied to the skin in a region surroundingthe soft tissue detect, in which region no tensile forces are exerted bythe apparatus on the fascia lying under the skin.

A further preferred refinement provides that the fastening device has apressure-distributing means that can be applied to the skin of thepatient. The pressure-distributing means can preferably be filled with amedium. As a medium for filling the pressure-distributing means, use maybe made of a gas, in particular air, a liquid, in particular water, or agel. The pressure-distributing means may have a chamber into which themedium can be introduced. By way of the pressure-distributing means,pressure forces acting on the skin of the patient can be distributeduniformly, such that the risk of the formation of pressure points on theskin is reduced. The fastening device particularly preferably has apressure-distributing means with multiple, in particular two, chambers.It is advantageous if the chambers are designed such that they can bealternately filled with a medium such that the pressure forces can beintroduced alternately into different regions of the skin. The chambersare preferably formed in the manner of concentric circles, wherein afirst chamber is in the form of a circular ring which surrounds a secondchamber.

In a preferred refinement, the fastening device has an implant which canbe fastened to a bone of the patient. The implant may be formed as aninternal fixator. The implant is particularly preferably an implant thatis already present in the body of the patient, such as for example aspinal column implant. It is alternatively possible for the implant tobe introduced together with the apparatus for reducing the retraction ofthe fasciae. The implant may have one or more longitudinal members. Thelongitudinal members of the implant may be fastenable to bones of thepatient, for example to vertebrae of the spinal column. For thefastening of the implant, in particular of the longitudinal members, tothe bones, the implant preferably comprises one or more connectingmeans, in particular one or more screws.

A preferred refinement provides that the apparatus has a forcemeasurement device for the measurement of the tensile force exerted onthe fascia by the tensile element. The force measurement device may bedesigned such that the sum of the tensile forces exerted by the varioustensile elements can be measured. The apparatus particularly preferablyhas multiple force measurement devices for the measurement of thetensile forces exerted by the various tensile elements. The forcemeasurement device may be designed such that the tensile force exertedby one tensile element, or the tensile force exerted by a group oftensile elements, can be measured in each case. The force measurementdevice may have a spring force sensor, an inductive force sensor, acapacitive force sensor, an optical force sensor, a strain gauge, amagnetic force sensor, an electromagnetic force sensor or apiezoelectric force sensor. The force measurement device may beconnected to a tensile element, in particular such that the forcemeasurement device is arranged in the force flow of the tensile force.Alternatively or in addition, the force measurement device may bearranged between the mounting bracket and the fastening device, inparticular in a strut provided between the mounting bracket and thefastening device. It is furthermore possible for the force measurementdevice to be formed as part of the fastening device, which has apressure-distributing means that can be filled with a medium, forexample a gel. Through measurement of the compression of the medium, theforce exerted on the pressure-distributing means can be determined.

The fastening device is particularly preferably designed such that itcan be sewn to the tissue, in particular the skin, of the patient.

It is advantageous if the mounting bracket can be attached to the bodyof the patient by way of multiple fastening devices, wherein thefastening devices are of different design. For example, a fasteningdevice in the form of a strap-type fastener may be used in the upperregion of the abdomen or of the thorax, and a fastening device that canbe fastened to a bone of the patient may be used in the lower region ofthe abdomen. Alternatively, the fastening devices may be of identicaldesign. For example, two fastening devices in the form of strap-typefasteners may be provided, in particular a first fastening device in theupper region of the abdomen or of the thorax and a second fasteningdevice in the lower region of the abdomen. A further alternativeconsists in that only a single fastening device is provided. It may beprovided that the single fastening device can be arranged either in theupper region of the abdomen or of the back or in the lower region of theabdomen or of the back.

A particularly advantageous refinement provides that the mountingbracket is mounted so as to be movable, in particular movable inpivotable fashion, relative to the fastening device. By way of such amounting, movements of the patient that may arise for example as aresult of respiration and/or coughing can be compensated. The mountingbracket may preferably be entirely arranged so as to be movable relativeto the patient. Alternatively, the mounting bracket may be rigidlycoupled to and/or formed in one piece with the fastening device.

The mounting bracket may be coupled for example to the fastening deviceby way of at least one joint, which is advantageously in the form of arotary joint or in the form of a ball joint. It is possible for multiplejoints to be provided on the mounting bracket, such that the mountingbracket can move relative to multiple fastening devices. In the case ofa mounting bracket formed in the manner of a frame with multiple framesections, the frame sections may be connected to one another by way ofjoints in order to permit movements of the frame sections relative toone another. Alternatively, the mounting bracket may be coupled to thefastening device by way of spring elements, for example by way ofresilient telescopic rods.

The mounting bracket is preferably connected in non-positively lockingfashion to the fastening device.

It is also preferable if the mounting bracket can be adapted to the bodyof the patient, such that the apparatus can be used for patients ofdifferent physical build. The mounting bracket may be of telescopableform and/or designed to be assemblable from multiple modules, such thatthe dimensions of the mounting bracket can be adjusted in accordancewith the physical build of the patient.

In this context, it is particularly preferable if the length of themounting bracket, in particular in a direction running vertically alongthe abdomen or the back, is adjustable. The length of the mountingbracket can be adjusted for example by way of a telescopable element, inparticular a telescopic rod. The telescopic rod may have a detent deviceby way of which the length of the telescopic rod can be fixed.

It is furthermore advantageous if the position of the mounting bracketrelative to the body can be adjusted. For variation of the position ofthe mounting bracket, use may be made of a telescopable element.

As an alternative to an attachment of the mounting bracket to thepatient, the mounting bracket may be attachable to a holder which isindependent of the patient, in particular to a bed or to a stretcher orto a holder that is supported on the ground. In the case of attachmentto a holder which is independent of the patient, it must be ensuredthat, when the patient changes position, the mounting bracket can bemoved together with the patient in order to be able to maintain thetensile force on the fascia unchanged.

The mounting bracket is preferably selectively attachable either to thepatient or to a holder which is independent of the patient, inparticular to a bed or to a stretcher, such that a switch can be madeback and forth between said two types of mounting bracket as required,or both types of mounting bracket may be utilized simultaneously. Theholder which is independent of the patient is particularly preferably inthe form of a boom extension, a bed mounting point attached to a bed, ora holder that is supported on the ground.

To achieve the object mentioned in the introduction, a sponge fornegative-pressure wound therapy is also proposed, which sponge has asubstantially triangular or substantially trapezoidal or substantiallysemicircular or substantially semioval or substantially semiellipticalcross section. Alternatively, the sponge may have a rectangular crosssection with a ratio of height to width in the range from 1/1 to 1/5.The sponge is preferably designed so as to fill a region between theedges of an open fascia and an apparatus, which acts on the fascia, forreducing the retraction of the edges of an open fascia.

In a preferred refinement, the sponge has an internally situated regionwith increased strength in relation to its surface, or has an internallysituated, non-deformable basic shape. This yields the advantage that thesponge exhibits increased stability.

To achieve the object mentioned in the introduction, a sponge fornegative-pressure wound therapy is also proposed, which sponge has arecess for receiving an in particular elongate object, for example amounting bracket, and/or the contour of which sponge is adapted to theouter contour of the mounting bracket. The mounting bracket of theabove-described apparatus can be covered by way of the sponge, such thatsealing can subsequently be performed by way of a sealing means, forexample a film. The sponge may have a cross section which substantiallyhas the shape of a sector of a circular ring.

In the case of a kit of the type mentioned in the introduction, it isproposed, for the purposes of achieving the object, that anabove-described apparatus for reducing the retraction of the edges of anopened fascia of a patient be provided.

The same advantages as those already described in on with the apparatusaccording to the invention for reducing the retraction of the edges ofan opened fascia of a patient can be achieved in this way.

An advantageous refinement of the kit provides that the kit additionallyhas a sealing means for sealing off the open soft tissue defect, inparticular the abdomen or the open back. The sealing means may be in theform of a film which, on that side of the sponge which is averted fromthe body, can be applied, in particular adhesively bonded, to the opensoft tissue defect, in particular the opened abdominal wall or the openback wall. By way of the sealing means, the body cavity, in particularthe abdominal cavity or the cavity situated within the back wall, can beclosed off in liquid-tight and gas-tight fashion. The sealing means maybe arranged such that the apparatus for reducing the retraction of theedges of an opened fascia is situated entirely or partially within theregion sealed off by the sealing means. The sealing means is preferablyin the form of a non-adhesive film that is impermeable to air. Thenon-adhesive film that is impermeable to air may lie directly on theapparatus for reducing the retraction of the fascia edges. Thenon-adhesive, air-impermeable film may be fixed to the body of thepatient by way of adhesive means, for example an adhesive film. Thesealing means advantageously has one or more, for example two, openings,through which a part of the apparatus for reducing the retraction of thefascia edges, for example a mounting bracket, can be led. In the regionof the opening there may be provided a sealing element, for example aring-shaped and/or adhesive sealing element or a sealing element in theform of a tensile device, by way of which the non-adhesive,air-impermeable film can be brought into sealing contact with theapparatus.

The kit preferably has a vacuum pump for generating a negative pressurein the body cavity, in particular in the abdominal cavity or in thecavity situated within the back wall, of the patient. By way of thevacuum pump, excess liquids and/or gases can be suctioned out of thebody cavity, in particular the abdominal cavity or the cavity situatedwithin the back wall.

It is advantageous if the apparatus for reducing the retraction of theedges of the opened fascia has a mounting bracket which can be arrangedoutside the body of the patient and to which there can be attached atensile element which can be connected to the fascia, and the kit has asponge, the contour of which is adapted to the outer contour of themounting bracket.

The features described in conjunction with the apparatus according tothe invention may be used individually or in combination in the case ofthe kit.

The achievement of the object mentioned in the introduction isfurthermore contributed to by a method for reducing the retraction ofthe edges of an open fascia of a patient with an open soft tissuedefect, in particular with an open abdominal wall or an open soft tissuedefect on the back, wherein a tensile force with a force componentdirected away from the body of the patient is exerted on the edges ofthe fascia such that the edges of the fascia are held under tension andspaced apart from one another and such that an open soft tissue defect,in particular an opened abdominal wall or an open soft tissue defect onthe back, remains present.

The method can be performed without the soft tissue detect, inparticular on the abdomen or on the back, being treated simultaneouslyby way of negative-pressure wound therapy. The method is preferablycarried out on a soft tissue defect, in particular on the abdomen orback, which is simultaneously being treated by way of negative-pressurewound therapy.

The features described in conjunction with the apparatus according tothe invention and the kit may be used individually or in combination inthe case of the method.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages and details of the invention will be described belowon basis of the exemplary embodiments illustrated in the figures, inwhich:

FIG. 1 is a schematic sectional illustration of a human abdomen along atransverse plane in the case of an opened abdomen;

FIG. 2 is a schematic sectional illustration of a human abdomen along atransverse plane with a temporary abdominal wall closure according tothe prior art during performance of negative-pressure wound therapy;

FIG. 3 is a schematic sectional illustration of a human abdomen along atransverse plane with an apparatus according to the invention forreducing the retraction of an opened fascia as per a first exemplaryembodiment of the invention;

FIG. 4 is a schematic sectional illustration of a human abdomen with akit according to the invention for treating an open abdomen with anapparatus as per FIG. 3;

FIG. 5 is a schematic frontal illustration of an open abdomen with anapparatus as per FIG. 3;

FIG. 6 is a schematic sectional illustration of a human abdomen along asagittal plane with an apparatus as per FIG. 3;

FIG. 7 is a schematic sectional illustration of a human abdomen along atransverse plane with an apparatus according to the invention forreducing the retraction of an opened fascia as per a second exemplaryembodiment of the invention;

FIG. 8 is a schematic sectional illustration of a human abdomen with akit according to the invention for treating an open abdomen with anapparatus as per FIG. 7;

FIG. 9 is a schematic frontal illustration of an open abdomen with anapparatus as per FIG. 7;

FIG. 10 is a schematic sectional illustration of a human abdomen along asagittal plane with an apparatus as per FIG. 7;

FIG. 11 is a schematic sectional illustration of a human abdomen along atransverse plane with an apparatus according to the invention forreducing the retraction of an opened fascia as per a third exemplaryembodiment of the invention;

FIG. 12 is a schematic sectional illustration of a human abdomen along atransverse plane with an apparatus according to the invention forreducing the retraction of an opened fascia as per a fourth exemplaryembodiment of the invention;

FIG. 13 is a schematic illustration of a mounting bracket; and

FIG. 14 is a schematic illustration of a human abdomen with a kitaccording to the invention for treating an open abdomen as per a furtherexemplary embodiment;

FIG. 15a is a schematic sectional illustration of an apparatus forreducing the retraction of an opened fascia as per a fifth exemplaryembodiment;

FIG. 15b is a schematic sectional illustration of the apparatus fromFIG. 15 a;

FIG. 15c is a schematic sectional illustration of a modification of theapparatus from FIG. 15 a;

FIG. 16 is a schematic illustration of an open back wall defect with anapparatus for reducing the retraction of an opened fascia;

FIG. 17 is a schematic sectional illustration of an open back walldefect along a sagittal plane with an apparatus as per FIG. 16;

FIG. 18 is a schematic sectional illustration of a human torso along thetransverse plane A-A′ from FIG. 17;

FIG. 19 is a schematic sectional illustration of a human torso along thetransverse plane B-B′ from FIG. 17;

FIG. 20 is a schematic sectional illustration of a human torso along thetransverse plane A-A′ from FIG. 17 with a kit according to the inventionfor treating an open back;

FIG. 21 is a schematic sectional illustration of a human torso along thetransverse plane B-B′ from FIG. 17 with a kit according to the inventionfor treating an open back with an apparatus as per FIG. 16; and

FIG. 22 shows a modification of the exemplary embodiment shown in FIG. 7with a diverting device.

EXEMPLARY EMBODIMENTS OF THE INVENTION

FIG. 1 illustrates a transverse section through an open human abdomen.The abdominal wall 2 is composed substantially of the skin 3, of theabdominal muscle 5 situated under the skin 3, and of the fasciae 4.Between the skin 3 and the abdominal muscle 5 there is arrangedsubcutaneous tissue (not illustrated in the figures). The fasciae 4 areof great importance for the stability of the abdominal wall 2. Thefasciae 4 enclose the abdominal muscle 5 and lie against that side ofthe skin 3 which faces toward the abdominal cavity 29.

In the case of some disease patterns which are associated with anintra-abdominal pressure increase, an abdominal compartment syndrome, itmay be necessary to lower the pressure by opening up the abdominal wall2 of the patient 1 and removing excess gases and/or liquids from theabdominal cavity 29 through abdominal wall opening 7 created by surgicalmeasures. Here, it may be the case that internal organs, for example theintestines 6, emerge through the abdominal wall opening 7.

To counteract the occurrence of infections in the abdominal cavity 29and to facilitate the care of the open abdomen, the abdominal wallopening 7 is generally temporarily sealed off, and negative-pressuretherapy is simultaneously performed. As can be seen from theillustration an FIG. 2, it is the case here that the abdominal cavity 29is covered for example by way of a sponge 8 arranged below the abdominalwall 2. Between the sponge 8 and the intestines 6 there is preferablyarranged a film (not illustrated in the figures) or a separatingmaterial for preventing the intestine 6 from drying out. A preferablyfurther sponge 9 is introduced into the abdominal wall opening 7, andthe abdominal wall opening 7, is sealed off by way of a sealing means30, which is normally in the form of a gas-tight adhesive film. Thesponge 9 is connected by way of a suction hose 10 to a vacuum pump. Byway of the vacuum pump, a negative pressure is applied such thatundesired liquids and/or gases can be removed from the abdominal cavity29 through the suction hose 10. Said negative-pressure therapy isgenerally performed over a duration of several days up to several weeks.A person skilled in the art understands that the abdominal wall opening7 may also be covered in some other way.

In order that the edges 4.1 of the fascia 4 do not unduly retract duringsaid time period, and the closure of the fascia 4, that is to say theconnection of the fascia edges 4.1, is possible with non-problematicwound healing after the period of the abdomen being open, an apparatus11 according to the invention for reducing the retraction of the fascia4 is inserted after the abdominal wall 2 is opened, of, FIG. 3.

As can be seen from the illustration in FIG. 3, by way of the apparatus11 according to the invention, tensile forces A, B with a forcecomponent A₁, B₁ directed away from the body of the patient 1 areexerted on the edges 4.1 of the fascia 4 such that the apparatus holdsthe edges 4.1 under tension and spaced apart from one another. Theabdominal wall 2, and thus also the fascia 4, is held open. Theabdominal wall opening 7 has an extent of greater than 1 cm, preferablyof greater than 5 cm, such that unhindered access to the abdominalcavity 29 is possible.

The apparatus 11 preferably has multiple tensile elements 12 by way ofwhich the tensile forces A, B are introduced into the fascia edges 4.1.The tensile elements 12 are preferably in the form of threads. Use mayalternatively be made of wires, cables or meshes. The tensile elements12 may be of elastic or non-elastic form. It is basically possible forthe tensile elements 12 to be connected directly to the fascia 4. Toprevent the tensile elements 12 from being torn out, and to preventdamage to the fascia 4, the tensile elements 12 are preferably connectedto the fascia by way of an areal connecting means 13 in the form of amesh. The areal connecting means 13 can distribute the considerabletensile forces over a relatively large area, and thus improve theintroduction into the fascia 4. The mesh may remain connected to thefascia 4 throughout the entire duration of the treatment of the openabdomen. The tensile elements 12 may however be exchanged as required.

The tensile elements 12 are connected by way of their respective sidesaverted from the fascia 4 to a mounting bracket 14. The mounting bracket14 is arranged outside the body of the patient 1 in the region in frontof the opened abdominal wall 2. The mounting bracket 14 is preferably inthe form of at least one rod which runs in a vertical direction alongthe abdominal wall opening 7 and which preferably extends approximatelyfrom the region of the sternum 26 to the anterior pelvic ring 27 of thepatient 1, cf. FIG. 5 and FIG. 6.

The attachment of the tensile elements 12 to the mounting bracket 14 maybe realized by virtue of the tensile elements 12 being led through apassage opening (not illustrated in the figures) in the mounting bracket14 and then, for example, being knotted. Alternatively, the tensileelements 12 may be attached to the mounting bracket 14 in each case byway of a tensioning apparatus arranged on the mounting bracket 14. Thetensioning apparatus may have a force booster. A further alternativeattachment of the tensile elements 12 to the mounting bracket 14 may berealized by way of channels arranged on the mounting bracket 14. Thetensile elements 12 may advantageously be led through the channels.

As also emerges from the illustrations in FIGS. 3-6, it is possible forall of the tensile elements 12 to be attached to the mounting bracket 14by way of connecting points which are arranged along a common straightline, whereby a compact construction is made possible. Alternatively,use may be made of a mounting bracket with a curved profile, such thatthe connecting points are arranged on a curved line, for example acircular line or the circumferential line of a closed curved line, forexample of an ellipse.

The mounting bracket 14 is preferably fixed to the body of the patient 1by way of two fastening devices 16, 17. The fastening devices 16, 17 arein the form of strap-type fasteners which are firmly strapped around thebody of the patient 1 in the region of the sternum 26 and in the regionof the anterior pelvic ring 27, such that slippage of the fasteningdevices 16, 17 is as far as possible prevented. The fastening device 17arranged in the region of the anterior pelvic ring 27 is preferablydesigned such that, with the fastening device 17 fitted, performing analhygiene is possible. Here, ventrally, the fastening devices 16, 17 havein each case one pressured-distributing means, for example a support inthe form of a gel a plate 18, 19, via which the mounting bracket 14 issupported on the body of the patient 1. Optionally, thepressure-distributing means may have multiple, in particular two, three,four, five or six chambers, which can be selectively filled with amedium such as water, air or gel. On the supports 18, 19 there arearranged in each case holding 20, 21 and a strut 22, 23 extending in aventral direction. By way of the supports 18, 19, the holding plates 20,21 and the struts 22, 23, the fastening devices 16, 17 are connected toboth ends of the mounting bracket 14.

The fastening devices 16, 17, the struts 22, 23 and the mounting bracket14 are designed such that they can be adapted to the physical build ofthe patient 1. The fastening devices 16, 17 may for example beadjustable in length, such that they can be adapted to the circumferenceof the body of the respective patient 1. The struts 22, 23 are forexample of telescopable form, for example in the form of telescopicstruts, such that the spacing of the two ends of the mounting bracket 14from the abdominal wall 2 can be individually adjusted. Furthermore, themounting bracket 14 is in particular of telescopable form, such that thelength of the mounting bracket 14 in a direction running verticallyalong the abdomen, that is to say in a direction parallel to aconnecting line from head to feet, can be adjusted. Alternatively, thestruts 22, 23 may be attached displaceably to the mounting bracket 14,such that the spacing of the struts 22, 23 to one another can be adaptedto the of the abdominal wall opening 7.

Spring means are preferably provided between the points at which thetensile elements 12 are attached to the mounting bracket 14. In the caseof a mounting bracket 14 of telescopable form, for example a telescopicbar, it is preferably the case that resilient telescopic elements arearranged between the points at which the tensile elements 12 areattached to the mounting bracket 14.

The struts 22, 23 are coupled to the mounting bracket 14 in each case byway of a joint 24, 25 which may be in the form of a ball joint or hinge.The mounting bracket 14 is thus mounted so as to be movable relative tothe struts 22, 23 and the respective fastening device 16, 17 connectedto the struts, such that movements of the patient 1 during respirationor coughing can be compensated. Alternatively, it is possible forselectively only the coupling between the upper fastening device 16 andthe mounting bracket 14 or only the coupling between the lower fasteningdevice 17 and the mounting bracket 14 to be realized by way of a joint,and for the respective other coupling of fastening device 16 or 17 andmounting bracket 14 to be of rigid form. As a further alternative, thefastening devices 16, 17 and the mounting bracket 14 may be rigidlycoupled. A further alternative provides that the struts 22, 23 arecoupled in each case by way of a joint to a fastening device 16, 17 orto a holding plate 20, 21.

As shown in FIG. 3, tensile forces A, B with a force component A₁, B₁directed away from the body are generated by way of the apparatus 11.The tensile forces A, B run substantially in a ventrolateral direction,that is to say they are directed laterally forward from the patient. Thefascia edges 4.1 are thus held with a spacing to one another which mayamount to more than 1 cm, preferably more than 5 cm. At the same time,the fascia edges 4.1 are stretched in a ventral direction V, that is tosay in a direction perpendicular to the imaginary connecting line of thefascia edges 4.1, and are prevented from retracting laterally. Bycontrast to apparatuses which generate only a force component in thedirection of the abdominal wall opening 7, it is possible with theapparatus according to the invention for treatment to be performed onthe open abdomen. The abdominal cavity 29 is thus enlarged is way of theabdominal wall opening 7 and the ventral displacement of the abdominalwall 2.

When the apparatus 11 is arranged on the body of the patient 1, theabdominal wall opening can be covered by way of sheets. Alternatively,negative-pressure wound therapy may be performed, as will be discussedin more detail below.

The constituent parts of a kit suitable for treatment of the openabdomen are illustrated in FIG. 4. Aside from the above-describedapparatus 11 for reducing the retraction of the edges 4.1 of an openedfascia 4, the kit has a sponge 15 which fills the abdominal wall opening7. The sponge 15 preferably has a substantially triangular cross sectionsuch that it fills the region delimited by the tensile elements 12between the edges 4.1 of the fascia and the mounting bracket 14. Thesponge 15 is preferably of dimensionally stable form. The sponge 15particularly preferably has an internally situated region with increasedstrength in relation to its surface, or an internally situated,non-deformable basic shape. The tensile elements 12 and the mountingbracket 14 may in particular be covered by a further sponge 31. Thesponge 31 is preferably designed so as to be connectable to the tensileelements 12. The sponge 31 may have a section whose shape is adapted tothe outer contour of the mounting bracket 14. On the externally situatedsurface of the sponge 31 there may preferably be arranged, a gas-tightand/or liquid-tight sealing means 30 (not of illustrated in thefigures), for example an adhesive film or a gas-tight sleeve. A suctionhose 10 may be connected to the sponge 31 such that negative-pressuretherapy described above in conjunction with FIG. 2 can be performed.

In a modification of the exemplary embodiment shown in FIGS. 3-6, thetensile elements 12 may preferably have spring means. By way of thespring means, the respective tensile element 12 can be preloaded in thedirection of the tensile force A, B and thus held under stress.

The second exemplary embodiment, shown in FIGS. 7-10, of an apparatus 11for reducing the retraction of the fascia edges 4.1 is substantiallyidentical to the first exemplary embodiment shown in FIGS. 3-6. Bycontrast to the first exemplary embodiment, multiple mounting brackets14 are provided in the case of the apparatus 11 as per FIGS. 7-10. Thetensile elements 12 connected to a first edge 4.1 a of the fascia 4 areconnected to a first mounting bracket 14, and the tensile elements 12connected to a second edge 4.1 b of the fascia 4 are connected to asecond mounting bracket 4. The mounting brackets 14 are separated fromone another by a spacing which corresponds substantially to the spacingof the two fascia edges 4.1 a, 4.1 b. The tensile forces A, B engage onthe fascia 4 in a substantially ventral direction V, that is to say thetensile force is directed forward as viewed from the patient A. In thesecond exemplary embodiment, the two mounting brackets 14 are arrangedparallel. Alternatively, said mounting brackets may be arrangedtransversely with respect to one another. Through the use of multiplemounting brackets 14, a free space is formed in the region in front ofthe abdominal wall opening 7, which free space provides easier access tothe open abdomen, cf. FIG. 7 and FIG. 9.

For the treatment of the open abdomen in the context ofnegative-pressure therapy, use may be made of a kit having a sponge 28inserted into the abdominal wall opening 7, which sponge preferably hasa rectangular or trapezoidal cross section, cf. FIG. 8. The kit mayotherwise be designed in the manner of the kit discussed on the basis ofFIG. 4.

In a modification of the second exemplary embodiment, the mountingbrackets 14 may be sections of a frame which can be arranged so as to bepositioned in front of the abdominal wall opening 7. The frame may havemultiple mounting brackets arranged in particular in parallel, whichmounting brackets may be arranged along the abdomen in a verticaldirection, that is to say parallel to an imaginary line from the head tothe feet of the patient 1. The frame may be preferably have multiplesections which are movable relative to one another. For example, thesections of the frame may be connected to one another by way of joints.

FIG. 11 illustrates a third exemplary embodiment of the invention. Bycontrast to the second exemplary embodiment, the spacing between themounting brackets 14 is greater than the spacing between the edges 4.1of the fascia 4. In the case of the apparatus 11 as per the thirdexemplary embodiment, it is the case in particular that tensile forcesA, B are exerted on the fascia edges 4.1, which tensile forces have aforce component which is directed away from the body and which runsparallel to an imaginary connecting line between the spaced-apart fasciaedges 4.1. The tensile forces A, B are in particular directedsubstantially parallel to the abdominal wall 2 of the patient 1 but awayfrom the abdominal wall opening 7. The tensile forces A, B engage on thefascia 4 substantially in a lateral direction W. The tensile forces A, Bengage on the fascia 4 preferably in a direction oriented away from themiddle of the abdominal wall opening 7, running parallel to theimaginary connecting line of the fascia edges 4.1. The fascia edges 4.1are in particular folded over about the skin edges 3.1.

FIG. 12 illustrates a fourth exemplary embodiment of the invention. Bycontrast to the first exemplary embodiment, the connecting means 13 isconnected not only to the fascia edges 4.1 but also to the skin edges3.1. By way of the apparatus 11 as per FIG. 12, a tensile force. A, Bwith a force component directed away from the body of the patient 1 canbe exerted on the edge 4.1, 3.1 of fascia 4 and skin 3 such that theapparatus 11 holds the edges 4.1, 3.1 of fascia 4 and skin 3 undertension and spaced apart from one another and such that, furthermore, anopened abdominal wall 2 is realized.

FIG. 13 shows an example of a mounting bracket 14 such as can be used inan apparatus 11 as per one of the exemplary embodiments described above.The mounting bracket 14 is in the form of a telescopic rod and has atleast two parts 14.1 and 14.2 which are movable relative to one another.A first part 14.1 has a larger cross section than a second part 14.2,such that the second part 14.2 can be pushed into the first part 14.1. Ajoint head 25 a ball joint may be integrally formed on or attached tothe second part.

The mounting bracket 14, in particular the parts 14.1, 14.2, havemultiple connecting points 14.3 by way of which the tensile elements 12can be attached.

Furthermore, connectors 32 may be provided which are designed such thatthey can be reversibly attached to the connecting points 14.3. Theconnecting points 14.3 are preferably in the form of openings. Theconnectors 32 are preferably designed such that they can be insertedinto the openings.

An elastic element 35, for example a spring, is optionally arranged inthe region between the connecting points 14.3 and that end of themounting bracket 14 which is connected to the support 18, 19, inparticular that end of the parts 14.1, 14.2. By way of the elasticelement 35, movements of those ends of the mounting bracket 14 which areconnected to the support 18, 19, in particular as result of respiratorymovements or coughing by the patient, can be absorbed. In a modificationof the exemplary embodiment as per FIG. 13, an elastic element 35 may bearranged in the region between two connecting points 14.3.

In the illustration in FIG. 13, two parts 14.1 and 14.2 are shown. It ispossible for the mounting bracket 14 to be designed so as to have atleast three parts, wherein the left-hand part 14.1 shown in FIG. 13forms a central part with a relatively large cross section, into whichthe two other parts 14.2 with a relatively small cross section can bepushed. On the central part 14.1 there may be provided a seal such thatthe length of the mounting bracket 14 can be varied by way of movementof the outer parts 14.2 relative to the central part 14.1, wherein theopened abdomen is sealed off. The seal may for example be formed in themanner of a sealing ring which sealingly surrounds the central part14.1. The outer parts 14.2 may be situated in a region which is notinvolved in the sealing of the abdominal cavity the sealing region. Theouter parts 14.2 may for example be arranged in front of the pubicregion of the patient.

The pubic region is not incorporated into the sealing region for thesealing of the abdominal cavity, because the application of sealelements is impeded there.

In a modification of this exemplary embodiment, a mounting bracket 14 ofunipartite form, in particular in the manner of a rod, may be provided,wherein one or more seals are provided on the mounting bracket 14. Theseals may be formed in the manner of sealing rings which sealinglysurround the mounting bracket 14, in particular the rod.

The illustration in FIG. 1A shows a refinement of the kit shown in FIG.4. By contrast to the kit as per FIG. 4, the kit as per FIG. 14additionally has a coveting sponge 33, the contour of which is adaptedto the outer contour of the mounting bracket 14. Furthermore, two sidesponges 34 are provided which can be applied at the outside to thesponge 15 and to the tensile elements 12.

FIG. 15a and FIG. 15b show a further exemplary embodiment of anapparatus 11 for preventing the retraction of the fasciae. The apparatus11 has a mounting bracket 14 via which tensile elements 12 in the formof threads, for example, can be attached. The mounting bracket 14 isrigidly connected to two struts 22, 23, by way of which them mountingbracket 14 can be held in a position spaced apart from the body of thepatient 1. The struts 22, 23 are in the form of telescopic struts, suchthat it is possible for the position of the mounting bracket 14 to beadjusted by way of the struts 22, 23. Furthermore, the struts 22, 23 aredisplaceable along the mounting bracket 14 and can be selectively fixedat different locations on the mounting bracket 14. It is thus possiblefor the spacing of the struts 22, 23 to be adapted to the size of thesoft tissue defect, for example to the size of the abdominal wallopening. The struts 22, 23 connect the mounting bracket 14 in each caseto a fastening device 16, 17 which lies on the skin 3 of the patient 1.

The struts 22, 23 have in each case two strut elements 2.1, 22.2, 23.123.2 which are, movable relative to one another. On the struts 22, 23there is provided in each case one fixing apparatus 38, 39, by way ofwhich the strut elements 22.1, 22.2, 23.1, 23.2 can be fixed relative toone another. The fixing apparatus 38, 39 may for example be formed inthe manner of a fixing screw.

The struts 22, 23 preferably have a force measurement device (not shownin the figures) by way of which the sum of the tensile force imparted bythe tensile elements can be measured. Alternatively, a force measurementdevice may be provided as part of the fastening device 16, 17.

The apparatus 11 is designed such that the tensile force engages on thefascia 4 in a direction which encloses an angle which lies in the rangefrom 5° to 90°, or in the range from 10° to 80°, or in the range from15° to 70°, with a virtual connecting line between the edges 4.1 of theopened fascia 4. The angle preferably lies in the range from 30° to 60°,particularly preferably in the range from 35° to 55°. For example, theangle may amount to substantially 45°. In relation to the longitudinalaxis of a strut 22, 23, the tensile force engages on the fascia 4 in adirection which encloses an angle which lies in the range from 0° to85°, or in the range from 10° to 80°, or in the range from 20° to 75°,with the longitudinal axis of the strut 22, 23. The angle preferablylies in the range from 30° to 60°, particularly preferably in the rangefrom 35° to 55°. For example, the angle may amount to substantially 45°.

On a side averted from the mounting bracket 14, the struts 22, 23 havein each case one joint 36, 37 by way of which the struts 22, 23 areconnected to a support 16, 19 of a fastening device 16, 17. Thefastening device 16, 17 may furthermore have one or more straps for thefixing of the supports 18, 19 to the patient 1. The joint 36, 37 ispreferably in the form of a ball joint. When the apparatus 11 isarranged on the body of a patient 1, the supports 18, 19 of thefastening devices 16, 17 are supported on the skin of the patient 1,preferably in a region of the skin in which no tensile forces areexerted by the apparatus 11 on the fascia lying under the skin.

Alternatively, the fastening devices 16, 17 may have a connecting regionby way of which the fastening devices 16, 17 can be fastened to a boneof the patient 1.

The mounting bracket 14 of the apparatus 11 has a two-part construction,which will be described in more detail below. The mounting bracket 14has a holding element 14.4, which is in particular connected rigidly tothe struts 22, 23, and an attachment element 14.5, which is movablerelative to the holding element 14.4. On the attachment, element 14.5there are provided multiple connecting points 14.3 by way of whichtensile elements 12 can be attached. The connecting points 14.3 are forexample in the form of bores. Connectors 32, which are in particular inthe form of eyebolts, are arranged in the connecting points 14.3.Alternatively, the connectors may be in the form of detent elements witheyelets, which can be inserted into the connecting points 14.3 andlocked with detent action in the connecting points. The position of theconnectors 32 relative to the attachment element 14.5 is adjustable,such that, by way of the adjustment of the position of the connectors32, the tension of the tensile elements 12 can be adjusted independentlyof one another. The connectors 32 thus form a tensioning device by wayof which the tension of the tensile elements 12 can be individuallyadjusted. The attachment element 14.5 is connected by way of multiplecables 40 or chains to the holding element 14.4, wherein a first end ofa cable 40 or a chain is fixedly fastened to the attachment element14.5. A second end of the cable 40 or of the chain is connected to ashaft 41 mounted in the holding element 14.4 such that the cable 40 orthe chain can be wound up when the shaft 41 is rotated. By way of therotation of the shaft 41, the position of the attachment element 14.5,and thus the tension of all of the tensile elements 12 attached to theattachment element 14.5, can be adjusted jointly. In this respect,groupwise adjustment of the tension of the tensile elements 12, oradjustment of the spacing between the holding element 14.4 and theattachment element 14.5, is made possible by way of the rotation of theshaft 41. The shaft 41 is connected by way of a fixing coupling 43 to anactuating element 44. The fixing coupling 43 is designed so as tonormally block a rotation of the shaft 41 and to permit a rotation ofthe shaft 41 only when the actuating element 44 is pulled out of themounting bracket 14, in particular out of the holding element 14.4, inthe direction of the axis of rotation of the shaft 41.

The attachment element 4.5 is exchangeable either separately from ortogether with the shaft 41 or a part of the shaft 41. The connectors 32may be exchanged together with the attachment element 14.5. A disposableattachment element is thus provided.

If the apparatus 11 is used in the context of negative-pressure woundtherapy, the mounting bracket 14 of the apparatus 11 may be arrangedsuch that the mounting bracket 14 is situated in the region that issealed off in gas-tight fashion. To permit re-tensioning of the tensileelements 12 even in the case of an applied negative-pressure woundbandage, the mounting bracket may be arranged such that the actuatingelement 42 is arranged outside the region that is sealed off ingas-tight fashion. To prevent an ingress of air through the mountingbracket 14 into the region that is sealed off in gas-tight fashion, themounting bracket 14 preferably has a housing that is sealed off ingas-tight fashion. For example, the holding element 14.4 may have one ormore seals 42 which seal off the shaft 42 with respect to the holdingelement 14.4. For sealing purposes, a non-adhesive, air-impermeable filmis used. The film has two openings through which the mounting bracket14, in particular the holding element 14.4, is guided. The film issealed off with respect to the mounting bracket 14, in particular theholding element 14.4, by way of sealing means.

FIG. 15c shows a modification of the exemplary embodiment shown in FIG.15a and FIG. 15b , in which the mounting bracket 14 has a holdingelement 14.4 and multiple, in particular two, attachment elements 14.5that are movable relative to the holding element 14.4. The attachmentelements 14.5 are connected to one another by way of a spacer element14.6. The spacing of the attachment elements 14.5 to one another isadjustable. For the adjustment of the spacing, the spacer element 14.6may be of telescopable form.

Below, on the basis of the illustrations in FIGS. 16-21, it is sought todescribe an exemplary embodiment of an apparatus 11 according to theinvention which is suitable for the treatment of an open back wall. Theopening of the back wall may be necessary for example for the treatmentof vertebral fractures, of spondylolisthesis, of vertebral disk damage,of constrictions of the spinal canal, of infections or tumors on thespinal column, and of dysplasia and malpositioning of the spinal column.In particular in the event of infections occurring after operations havetaken place, it is sometimes possible for the back wall to be left openfor the purposes of infection treatment. To counteract the occurrence ofinfections and facilitate the care of the open back wall, the back walldefect is generally temporarily sealed off. Negative-pressure woundtherapy may optionally be performed.

In the region of the back, a fascia 4 encloses the back muscle 56 thatlies under the skin 3.

The apparatus 11 for preventing the retraction of the fasciae 4 has amounting bracket 14 which is formed in the manner of a rod and which isconnected to struts 22, 23. The struts 22, 23 connect the mountingbracket 14 to a fastening device which is in the form of an implantalready arranged in the body of the patient, that is to say as aninternal fixator. The implant is composed of multiple, in particulartwo, longitudinal bars 52 which are fixed to the pedicle screws 51 byway of grub screws (not shown in the figures). The pedicle screws 51extend through the pedicle of the vertebra 50 and extend into the regionof the vertebral body of the vertebra 50. The implant has multiplelongitudinal rods 52 which are in each case connected to the pediclescrews 51 in two or more vertebrae 50 and which fix the position of saidvertebrae 50 relative to one another.

Tensile elements 12 may be attached to the mounting bracket 14, by wayof which tensile elements tensile forces can be exerted on the fasciaedges 4.1. Said tensile elements 12 are preferably in the form ofthreads, wires, cables or meshes. The tensile elements 12 may be ofelastic or non-elastic form. It is basically possible for the tensileelements 12 to be connected directly to the fascia 4. To prevent thetensile elements 12 from being torn out, and to prevent damage to thefascia 4, the tensile elements 12 are preferably connected to the fasciaby way of an areal connecting means 13 in the form of a mesh.

As can be seen from the illustrations in FIGS. 18-21, the mountingbracket 14 is arranged outside the body of the patient 1 with a certainspacing to the open defect in the skin 3. In a modification of theexemplary embodiment, it is possible for the mounting bracket 14 to bearranged in the plane of the skin defect or to the inside of the planeof the skin defect but outside the plane of the fascia defect. In afurther modification, the apparatus according to this exemplaryembodiment may have multiple mounting brackets 14. It is for examplepossible for the tensile elements 12 to be attached to multiple mountingbrackets 14 which are in the form of rods running substantiallyparallel, as has been described above in conjunction with theillustrations in FIGS. 7 and 8 with regard to use in the region of theabdomen.

The illustrations in FIGS. 20 and 21 show the constituent parts of a kitfor treating an open skin defect in the form of an open back wall. Thekit has not only the above-described apparatus 11 for reducing theretraction of the edges 4.1 of an opened fascia 4 but also a firstsponge 54 which is adapted to the contour of the vertebra 50 such thatthe spinous process 53 of the vertebra 50 engages into a recess of thesponge 54. Furthermore, the first sponge 54 has openings through whichthe struts 22, 23 of the apparatus 11 can be guided. Furthermore, asecond sponge 15 is part of the kit, wherein the second sponge 15 fillsthe skin defect. The second sponge preferably has a substantiallytriangular cross section such that it fills the region delimited by thetensile elements 12 between the edges 4 of the fascia and the mountingbracket. The sponge 15 is preferably of dimensionally stable form. Thesponge 15 particularly preferably has an internally situated region withincreased strength in relation to its surface, or an internallysituated, non-deformable basic shape. The tensile elements 12 and themounting brace 14 may in particular be covered by a third sponge 31. Thethird sponge 31 is preferably designed to be connectable to the tensileelements 12. The third sponge 31 may have a section whose shape isadapted to the outer contour of the mounting bracket 14. On theexternally situated surface of the third sponge 31 there may preferablybe arranged a gas-tight and/or liquid-tight sealing means (notillustrated in the figures), for example an adhesive film or anon-adhesive film that is impermeable to air. A suction hose 10 may beattached to the third sponge 31, such that negative-pressure therapy asdescribed above in conjunction with FIG. 2 can be performed.

In the case of the above-described apparatuses 11 for reducing theretraction of the edges 4.1 of a fascia 4, it is optionally possible fora diverting device 55 for the diversion of the tensile elements 12 to beprovided. A diverting device of said type is shown by way of example inFIG. 22. The diverting device is formed in the manner of a rod aroundwhich the tensile element 12 is guided. The tensile element 12 thus runsfrom the fascia 4 over the diverting device 55 to the mounting bracket14.

The above-described kits for treating an open soft tissue defect, inparticular an open abdominal wall 2 or an open soft tissue defect on theback, having at least one sponge 15, 28 for filling a soft tissuedefect, in particular an abdominal wall opening or an open soft tissuedefect on the back, each have an apparatus 11 for reducing theretraction of the edges of an opened fascia 4 of a patient 1 with anopen soft tissue defect, in particular with an open abdominal wall 2 oran open soft tissue defect on the back, by way of which apparatus atensile force with a force component A₁, B₁ directed away from the bodyof the patient can be exerted on the edges of the fascia 4 such that theapparatus 11 holds the edges of the fascia 4 under tension and spacedapart from one another and such that an open soft tissue defect, inparticular an opened abdominal wall or an open soft tissue defect on theback, remains present.

By way of the apparatus 11 according to the invention, the fascia 4 canbe held open to such an extent that the body cavity, in particular theabdominal cavity 29 or the cavity situated to the inside of the backwall, is freely accessible, and/or the internal organs 6 can emerge atleast substantially unhindered through the open soft tissue defect, inparticular the abdominal wall opening 7 or an open soft tissue defect onthe back. Furthermore, the apparatus 11 may be used to stretch a fascia4 whose edges 4.1 have already retracted. The apparatus according to theinvention may be used without negative-pressure wound therapy beingperformed.

LIST OF REFERENCE DESIGNATIONS

1 Patient

2 Abdominal wall

3 Skin

3.1 Skin edge

4 Fascia

4.1 Fascia edge

4.1 a, 4.1 b Fascia edge

5 Abdominal muscle

6 Intestine

7 Abdominal wall opening

8, 9 Sponge

10 Suction hose

11 Apparatus for reducing the retraction of the fascia

12 Tensile element

13 Connecting means

14 Mounting bracket

14.1, 14.2 Parts

14.3 Connecting point

14.4 Holding element

14.5 Attachment element

14.6 Spacer element

15 Sponge

16, 17 Fastening device

18, 19 Support

20, 21 Holding plate

22, 23 Strut

22.1, 22.2 Strut element

23.1, 23.2 Strut element

24, 25 Joint

25 a Joint head

26 Sternum

27 Anterior pelvic ring

28 Sponge

29 Abdominal cavity

30 Sealing means

31 Sponge

32 Connector

33 Covering sponge

34 Side sponge

35 Elastic element

36, 37 Joint

38, 39 Fixing apparatus

40 Cable

41 Shaft

42 Seal

43 Fixing coupling

44 Actuating element

50 Vertebra

51 Pedicle screw

52 Longitudinal bar

53 Spinous process

54 Sponge

55 Diverting device

56 Back muscle

A, B Tensile force

A₁, B₁, A₂, B₂ Force component

L Length

V Ventral direction

W Lateral direction

The invention claimed is:
 1. An apparatus for reducing a retraction ofedges of an open fascia of a patient with an open soft tissue defect, byway of which apparatus a tensile force with a force component directedaway from a body of a patient can be exerted on the edges of the fasciasuch that the apparatus holds the edges of the fascia under tension andspaced apart from one another and such that the open soft tissue defect,in particular an opened abdominal wall or an open soft tissue defect ona back, remains present; wherein the apparatus further includes: atleast one tensile element that can be connected to the fascia; amounting bracket, which can be arranged outside the body of the patientin front of the soft tissue defect and to which the at least one tensileelement can be attached, wherein the mounting bracket is attachable to aholder which is independent of the patient; and a force measurementdevice for measuring a tensile force exerted on the fascia by the atleast one tensile element.
 2. The apparatus as claimed in claim 1,wherein the tensile force engages on the fascia substantially in aventral direction or in a ventrolateral direction or in a lateraldirection or in a dorsal direction or in a dorsolateral direction. 3.The apparatus as claimed in claim 1, wherein the at least one tensileelement is in a form of a thread and/or in a form of a wire and/or in aform of a mesh.
 4. The apparatus as claimed in claim 1, wherein the atleast one tensile element has a spring means.
 5. The apparatus asclaimed in claim 1, wherein the at least one tensile element can beconnected to the fascia, or to an entire soft tissue mantle, directly orby way of a connecting means of areal form.
 6. The apparatus as claimedin claim 1, wherein the tensile force can be adjusted by way of atensioning apparatus arranged on the mounting bracket, which tensioningapparatus has a force booster.
 7. The apparatus as claimed in claim 1,wherein the mounting bracket can be arranged so as to run verticallyalong an abdomen or vertically along the back.
 8. The apparatus asclaimed in claim 1, wherein the mounting bracket is coupled to afastening device by way of at least one joint.
 9. The apparatus asclaimed in claim 1, wherein a length of the mounting bracket can beadjusted in a direction running vertically along an abdomen.
 10. Theapparatus as claimed in claim 1, wherein the holder that is independentof the patient is in a form of a boom extension or a bed mounting pointattached to a bed or a holder that is supported on a ground.
 11. Theapparatus as claimed in claim 1, wherein the mounting bracket comprisesone or more rods.
 12. The apparatus as claimed in claim 1, wherein theapparatus comprises various tensile elements that can be connected tothe fascia, wherein the force measurement device is designed such that asum of the tensile forces exerted by the various tensile elements can bemeasured.
 13. The apparatus as claimed in claim 1, wherein the forcemeasurement device comprises a spring force sensor or an inductive forcesensor or a capacitive force sensor or an optical force sensor or astrain gauge or a magnetic force sensor or an electromagnetic forcesensor or a piezoelectric force sensor.
 14. A kit for treating an opensoft tissue defect having at least one sponge for filling the open softtissue defect, comprising the apparatus for reducing the retraction ofthe edges of the open fascia of the patient as claimed in claim
 1. 15.The kit as claimed in claim 14, wherein the kit has a sponge, a contourof which is adapted to an outer contour of the mounting bracket.
 16. Thekit as claimed in claim 14, wherein the kit has a sealing means forsealing off the open soft tissue defect, which sealing means is in aform of a non-adhesive film that is impermeable to air.
 17. A method forreducing a retraction of edges of an open fascia of a patient with anopen soft tissue defect; wherein a tensile force with a force componentdirected away from a body of the patient is exerted on the edges of thefascia such that the edges of the fascia are held under tension andspaced apart from one another and such that the open soft tissue defect,in particular an opened abdominal wall or an open soft tissue defect ona back, remains present; wherein at least one tensile element isconnected to the fascia; wherein a mounting bracket is arranged outsidethe body of the patient in front of the soft tissue defect and the atleast one tensile element is attached to the mounting bracket; whereinthe mounting bracket is attached to a holder which is independent of thepatient; and wherein a force measurement device measures a tensile forceexerted on the fascia by the at least one tensile element.